News & Updates

Back to All News

AstraZeneca establishes Scientific Review Board to support clinical trial data transparency commitment

Lankenau Medical Center March 19, 2015 News Releases

AstraZeneca today announced the creation of a Scientific Review Board that will act independently to assess requests from external researchers which include patient level data. The Board of independent clinicians and academics has been established as part of AstraZeneca’s commitment to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) Responsible Data Sharing Principles, as well as the new European Medicines Agency Clinical Trial Policy and Regulation.

The Board is chaired by Peter Kowey, MD, System Chief, Division of Cardiovascular Diseases for the Lankenau Heart Institute, part of Main Line Health. The other members of the Board are:

  • Stephen Rennard, MD, Larson Professor of Medicine, University of Nebraska Medical Centre
  • Simon Day, PhD, Director, Clinical Trials Consulting and Training
  • Alexander Walker, MD DrPH, Principal, World Health Information Science Consultants, LLC

The Scientific Review Board will meet on a regular basis to consider all external requests for access to data from AstraZeneca clinical trials. The Board will assess the scientific validity of each request and how provision of the information may enhance scientific understanding and patient care. In addition to approving or rejecting requests, the Board will also have the option of granting conditional approvals or providing suggestions on how to resubmit requests in order to secure approval.

Professor Peter Kowey, Chair of the Board, said: “I am excited to be leading the Scientific Review Board for AstraZeneca and contributing to furthering transparency for the purposes of developing better drugs to help patients across the globe.”

The creation of the Scientific Review Board is part of AstraZeneca’s broader Clinical Trial Transparency Policy, which includes posting the results of all AstraZeneca sponsored clinical trials in all stages of clinical development on several public websites, regardless of outcome. Other new components of the AstraZeneca policy that will be implemented in 2015 include:

  • Creation of a Data Transparency Portal through which researchers can submit requests to access anonymized patient level data.
  • Creation of Lay Language Summaries of clinical trial results, to be made available to all patients that participate in AstraZeneca sponsored clinical trials, and publicly through websites including astrazenecaclinicaltrials.com.
  • Clinical Data packages, including Clinical Overviews and Clinical Summaries, Clinical Study Reports, and some of their Appendices (Study Protocols, sample Case Report Forms and Study Statistical Analysis Plans), to be made available via astrazenecaclinicaltrials.com and the new EU portal when it comes online in 2016.

Dr Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “AstraZeneca has a longstanding commitment to clinical trial transparency and these new developments are part of the evolution of that policy. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients. We are delighted to underpin our policy with the establishment of the Scientific Review Board and are pleased to have such an experienced panel on board to support us.”

To access AstraZeneca’s dedicated website and for more information on the Company’s clinical trial data disclosure commitment, visit astrazenecaclinicaltrials.com.

About Main Line Health

Founded in 1985, Main Line Health is a not-for-profit health system serving Philadelphia and its western suburbs. Main Line Health's commitment—to deliver advanced medicine for treating and curing disease, playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to be the region's premier choice for clinical care, research, and education. A team of more than 10,000 employees, 3,000 nurses and 2,000 physicians care for patients throughout the Main Line Health System.

At Main Line Health's core are four of the region's most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation's premier facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare, one of the region's largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care, and service, including U.S. News & World Report's Best Hospitals, System Magnet® designation; the nation's highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect, equity, and inclusion, has proudly received awards in this area and has embraced the American Hospital Association's #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education, and research to help patients stay healthy and live their best lives.

For more information, visit mainlinehealth.org and connect with us on social media:

Linkedin: www.linkedin.com/company/main-line-health
Facebook: www.facebook.com/mainlinehealth
Twitter: www.twitter.com/mainlinehealth
Instagram: www.instagram.com/mainlinehealth